DATA SAFETY MONITORING PLAN

数据安全监控计划

• 批准号: 7944930
• 负责人: BRIAN LEYLAND-JONES
• 金额: $ 1.48万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-07 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7944930
• 关键词: Address; Adherence; Adverse event; Agreement; Annual Reports; Benefits and Risks; Cancer Center Support Grant; Case Study; Categories; Clinical; Clinical Research; Clinical Trials; Confidentiality; Consultations; Data; Data Protection; Devices; Distant; Dose; Drug Industry; Drug usage; Elements; Enrollment; Ensure; Faculty; Failure; Follow-Up Studies; Frequencies; Futility; Guidelines; Institutes; Institution; Laboratories; Lead; Malignant Neoplasms; Methods; Monitor; Monitoring Clinical Trials; Multicenter Trials; Nurse Administrator; Nurses; Nursing Research; Outcome; Participant; Personal Satisfaction; Pharmacologic Substance; Phase; Phase I Clinical Trials; Phase III Clinical Trials; Physician Executives; Policies; Principal Investigator; Privacy; Procedures; Process; Progress Reports; Protocols documentation; Recommendation; Regulatory Affairs; Reporting; Research Ethics Committees; Research Infrastructure; Research Personnel; Risk; Role; Safety; Schedule; Site; Specific qualifier value; Visit; Voting; Writing; base; cooperative study; data integrity; member; minimal risk; patient safety; programs; response; tumor; working group

Overview of DSMP: Every clinical study conducted by the Winship Cancer Institute (WCI) and its Clinical Trials Office (CTO) is required to have a data safety and monitoring plan (DSMP) that describes how the study will be audited for safety and data integrity including the reporting of adverse events. The general elements of a DSMP are (1) Adverse Event Reporting, including a description of adverse event determination/reporting procedures; proposed adverse event reporting schedules; determination regarding who is to receive adverse event reports; (2) Data, Safety and Progress Reporting with a timetable for data submission and monitoring; (3) Rules to trigger study closure including the rules and processes for implementing study closure based upon significant risks, benefits, or study futility determination and procedures and guidelines for unblinding/unmasking; (4) Methods for ensuring protection of data confidentiality and study privacy; and (5) Review of PI qualifications to conduct the particular clinical study for which DSMP is being considered. The Monitoring Office will coordinate, conduct and/or oversee all clinical trial monitoring. All investigatorinitiated interventional trials will be audited annually. The Monitoring Committee (DSMC) will review all reports of monitoring activities of active protocols annually. These reviews are in addition to the reporting requirements established by the IRB, which may include semi-annual as well as annual reports. The DSMC will also be responsible for overseeing all Phase I investigator-initiated trials.

DSMP概述：由Winship癌症研究所（WCI）进行的每项临床研究及其 要求临床试验办公室（CTO）制定数据安全和监测计划（DSMP）， 描述了如何对研究的安全性和数据完整性进行稽查，包括不良反应的报告 事件DSMP的一般要素是（1）不良事件报告，包括描述 不良事件确定/报告程序;拟定的不良事件报告时间表; 确定谁将接收不良事件报告;（2）数据、安全性和进展 报告数据提交和监测的时间表;（3）触发研究关闭的规则 包括基于重大风险实施研究关闭的规则和流程， 获益或研究无效性确定以及揭盲/揭盲的程序和指南;（4） 确保数据机密性和研究隐私保护的方法;和（5）PI审查 进行正在考虑DSMP的特定临床研究的资格。的 监查办公室将协调、实施和/或监督所有临床试验监查。所有启动的 干预性试验将每年进行一次稽查。监督委员会（DSMC）将审查 每年对现行议定书的监测活动的所有报告。这些审查是除了 IRB规定的报告要求，可能包括每半年和每年 报道DSMC还将负责监督所有I期临床试验。